Actively Recruiting
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer
Led by Fudan University · Updated on 2023-06-15
1736
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of docetaxel plus carboplatin (TCb) regimen compared with conventional chemotherapy regimen (epirubicin plus cyclophosphamide followed by docetaxel, EC-T) regimen as adjuvant chemotherapy in patients with early-stage high-risk estrogen receptor (ER) positive and human epidermal growth factor receptor 2 (HER2) negative (ER+/HER2-) breast cancer.
CONDITIONS
Official Title
TCb vs EC-T in High Risk ER+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Unilateral invasive carcinoma confirmed by histology
- Eligible for surgery with no absolute contraindications
- No visible tumor remains after surgery
- Adjuvant chemotherapy to start within eight weeks after surgery
- Hormone receptor-positive, HER2-negative breast cancer with at least 4 positive lymph nodes
- Estrogen receptor or progesterone receptor positive by immunohistochemistry
- No evidence of metastasis before surgery
- No peripheral neuropathy
- ECOG physical status score of 0 or 1
- Good recovery from surgery with at least one week interval after surgery
- Adequate blood counts and organ function within 28 days before treatment
- Women of childbearing potential agree to effective contraception during and after treatment
- Cardiac function with left ventricular ejection fraction over 50%
- Signed informed consent form
You will not qualify if you...
- History of invasive cancer
- T4 clinical tumors including inflammatory breast cancer
- Prior systemic anticancer therapy for current breast cancer
- Previous treatment with anthracyclines or taxane drugs for any cancer
- History of certain breast cancer in situ with prior systemic therapy
- Severe cardiopulmonary dysfunction or recent myocardial infarction
- Malignancy diagnosed within the last 5 years except certain treated cancers
- Allergies to study drugs or growth factor agents
- Serious infections within 4 weeks before study treatment
- Pregnant or breastfeeding women or planning pregnancy during study
- Poorly controlled high blood pressure
- Mental illness or cognitive impairment preventing trial participation
- Lack of legal capacity or independence to consent or follow trial procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here